Study on Stereotactic Radiosurgery for Patients with More Than 3 Melanoma Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01644591

Provider View

This clinical trial is exploring the effectiveness of a specialized radiation treatment called stereotactic radiosurgery for patients with melanoma that has spread to more than three areas in the brain. The treatment aims to target tumors directly while minimizing damage to surrounding healthy tissue.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well stereotactic radiosurgery (SRS) works in controlling brain tumors in patients with melanoma that has spread to more than three locations in the brain. SRS is a precise form of radiation therapy that delivers a high dose of radiation directly to the tumor, potentially causing less harm to normal brain tissue. The study will also assess the impact of this treatment on patients' cognitive functions, such as memory and learning, compared to whole brain radiation therapy.

Description

The main goals of this study are to see if stereotactic radiosurgery (SRS) can effectively control brain tumors in patients with more than three melanoma brain metastases and to evaluate any cognitive changes, like memory decline, after treatment. Researchers will compare these outcomes to those of patients receiving whole brain radiation therapy.

Secondary goals include monitoring tumor control at various intervals (1, 4, 6, 9, and 12 months), overall survival rates, and changes in cognitive functions such as memory, attention, and motor skills. The study will also look at factors like age, overall health, and specific genetic mutations to predict treatment outcomes.

Additionally, researchers will explore whether certain genetic markers or inflammatory substances in the body can predict cognitive changes after radiation. The study will involve a single session of SRS, followed by regular check-ups for a year to monitor progress and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with malignant melanoma, confirmed by tissue sample from the primary or another metastatic site.
  • More than three melanoma brain metastases identified on a brain MRI scan within four weeks before joining the study.
  • Must sign an informed consent form acknowledging the experimental nature of the study.
  • Have a Karnofsky performance status (KPS) of 70 or higher, indicating the ability to care for oneself with some assistance.
  • Eligible to have all brain lesions treated, as determined by the study's radiation oncologist.
  • Adequate kidney function with creatinine clearance over 30 ml/min.
  • Platelet count above 50,000.
  • Normal blood clotting ability and able to pause blood-thinning medications around the time of treatment.
  • May continue other cancer treatments, like temozolomide, as advised by their oncologist.

Exclusion Criteria

  • Have received whole brain radiotherapy within the last three months.
  • Have a history of other metastatic cancers or uncontrolled non-metastatic cancers, except for localized skin cancers like squamous or basal cell carcinoma.
  • Show signs of cancer spread to the brain's lining (leptomeningeal disease) on scans or spinal fluid tests.
  • Female patients who are pregnant or breastfeeding, due to potential risks from the treatment.
  • Have a known allergy to gadolinium, a contrast agent used in MRI scans.
  • Unable to undergo an MRI scan for any reason.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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